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AtriCure Cryo Module

FDA 510(k)

Class II (US FDA 510(k))

510(k) K111042

by Atricure, Inc.

Identifiers

510(k) Number
K111042 FDA 510(k)
FDA Product Code
GEH FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4350 FDA 510(k)
Regulation Number
878.4350 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The AtriCure Cryo Module is a cryosurgical device used in conjunction with cryoablation probes for the treatment of cardiac arrhythmias. It functions by freezing target tissues to create an inflammatory response (cryonecrosis) that blocks electrical conduction pathways in the heart.

This device is supplied as a sterile, single-use system and is compatible with the AtriCure Cryo Module or Frigitronics CCS-200 Cardiac Cryosurgical System. It is regulated under FDA 510K clearance with product code GEH and is intended for use in general and plastic surgery applications.

Frequently asked questions

What is the AtriCure Cryo Module used for?

The AtriCure Cryo Module is a cryosurgical device used with cryoablation probes to treat cardiac arrhythmias by freezing target tissues to create an inflammatory response that blocks electrical conduction pathways in the heart.

How is the AtriCure Cryo Module supplied?

The device is supplied as a sterile, single-use system and is compatible with either the AtriCure Cryo Module or the Frigitronics CCS-200 Cardiac Cryosurgical System for use in general and plastic surgery applications.

What is the regulatory status of the AtriCure Cryo Module?

The AtriCure Cryo Module is regulated under FDA 510K clearance with product code GEH and has been determined to be substantially equivalent to predicate devices in the general and plastic surgery specialty.

Is the AtriCure Cryo Module reusable or single-use?

The AtriCure Cryo Module is supplied as a sterile, single-use system, meaning it is designed for one patient procedure only and should not be reused or resterilized for subsequent use.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: cryoICE Cryoablation Probes | Ablation Therapy - AtriCure, Inc., PDF Atricure Cryo Module System 510(K) Summary, ATRICURE ACM1 USER MANUAL Pdf Download | ManualsLib, ATRICURE CRYOICE BOX ACM1 USER MANUAL Pdf Download

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Atricure, Inc.

Sources (1)

  • FDA 510(k) K111042 24 fields · synced Sep 27, 2026